FDA 510(k)

YO Home Sperm Test

K-Number: K161493 · 2016-11-08

ApplicantMedical Electronic Systems , Ltd.

Decision Date2016-11-08

Product CodePOV

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

YO Home Sperm Test is a medical device manufactured by Medical Electronic Systems , Ltd.. It received FDA 510(k) clearance on 2016-11-08 under approval number K161493. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YO Home Sperm Test?

YO Home Sperm Test is a medical device that received FDA 510(k) clearance on 2016-11-08. It is manufactured by Medical Electronic Systems , Ltd.. The 510(k) number is K161493.

When was YO Home Sperm Test approved by the FDA?

YO Home Sperm Test received FDA 510(k) clearance on 2016-11-08, under approval number K161493.

What company makes YO Home Sperm Test?

YO Home Sperm Test is manufactured by Medical Electronic Systems , Ltd..

What is the FDA product code for YO Home Sperm Test?

The FDA product code for YO Home Sperm Test is POV.

Other Devices by Medical Electronic Systems , Ltd.

K220828SQA-iO Sperm Quality Analyzer K241628YO Home Sperm Test K243114SQA-iOw Sperm Quality Analyzer

Related Devices (Code: POV)

K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerBonraybio Co., Ltd. K183602SwimCount Sperm Quality TestMotilitycount Aps K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd. K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.